Showing 1481-1490 of 1555 results for "".
- Direct-to-Consumer Pharmaceutical Advertising: Minimizing Risks?https://practicaldermatology.com/news/20120912-letter_to_editor_discusses_changes_in_direct-to-consumer_pharmaceutical_advertising/2459741/When prescription drugs switch to over-the-counter status, regulatory oversight of their advertising shifts to the Federal Trade Commission (FTC), potentially leading to reduced focus on warnings about risks and side effects, a new report suggests. While the FDA regulates prescription drug advertisi
- Nomir Medical Submits 510(k) Application to FDA for Onychomycosishttps://practicaldermatology.com/news/20120911-nomir_medical_announces_510k_application_to_fda_for_onychomycosis/2459742/Nomir Medical Technologies, Inc. submitted a 510(k) application to the US Food and Drug Administration (FDA) for the indication of temporary increase of clear nail in patients with onychomycosis (toenail fungus). This 510(k) submission to FDA
- Abbott 2Q Profit Beats Expectations, Humira Sales Growhttps://practicaldermatology.com/news/20120802-abbott_2q_profit_beats_expectations_humira_sales_grow/2459757/Abbott Laboratories announced that second-quarter earnings narrowly beat estimates, fueled by the continued growth of its drug Humira. The company said net income for the quarter declined to $1.75 billion, or $1.08 per share, from $1.94 b
- Syneron Receives FDA Clearance for elōs Plushttps://practicaldermatology.com/news/20120712-syneron_receives_fda_clearance_for_els_plus/2459774/Syneron Medical Ltd. (NASDAQ: ELOS) received US Food and Drug Administration (FDA) clearance for elōs Plus, a multi-platform system featuring the company's proprietary elōs technology of optical energy and bi-polar radiofrequency. The FDA clearance follo
- FDA Extends Deadline for Sunscreen Label Compliancehttps://practicaldermatology.com/news/20120514-fda_extends_deadline_for_sunscreen_compliance/2459802/Sunscreen manufacturers have won a small victory from the Food and Drug Administration (FDA), which has extended the deadline for compliance with new labeling back to December 2013 for some companies. The industry pushed back on the agency, which ordered changes to sunscreens last summer with an ori
- Enrollments Complete for Two Phase 2 ALA-PDT AK Trialshttps://practicaldermatology.com/news/20120424-enrollments_complete_for_two_phase_2_ala-pdt_ak_trials/2459815/DUSA Pharmaceuticals (NASDAQ GM: DUSA) completed patient enrollment in its Phase 2 clinical trial studying the broad area application with 1-, 2-, and 3-hour drug incubation for the treatment of actinic keratoses (AKs) of the face or scalp
- FDA Seeks More Information on Pliaglishttps://practicaldermatology.com/news/20120419-fda_seeks_more_information_on_pliaglis/2459818/FDA's Complete Response Letter to Galderma Laboratories LP outlines additional information the FDA requires before it will approve the sNDA for Pliaglis, developer Nuvo Research, Inc. reports. The response is to the supplemental New Drug App
- Kythera Initiates Phase 3 trials for Investigational Injectablehttps://practicaldermatology.com/news/20120320-kythera_initiates_phase_3_trials_for_investigational_injectable/2459841/Kythera Biopharmaceuticals has initiated two Phase 3 trials of ATX-101, a first-in-class injectable drug under clinical investigation for the reduction of submental fat. The Phase 3 trials, known as REFINE-1 and REFINE-2 (Randomized Doubl
- FDA's 45-day TV ad reviewhttps://practicaldermatology.com/news/20120313-fdas_45-day_tv_ad_review_shot_clock_in_guidance/2459846/TV ads for most prescription drugs must be submitted to FDA for pre-review 45 days before the manufacturer intends to air them, according to an FDA draft guidance in tomorrow's Federal Register. The guidance isn't a bolt from the blue but rather a case of the agency catching up on old business – i
- Syneron to Acquire TransPharma Medicalhttps://practicaldermatology.com/news/20120313-syneron_to_acquire_transpharma_medical/2459847/Syneron Medical Ltd. (NASDAQ: ELOS) has signed a definitive agreement to acquire substantially all the assets of TransPharma Medical Ltd. TransPharma Medical, a specialty pharmaceutical company focused on the development and commercialization of drug-